7Microlife NEB 200
EN
Class II device as regards protection against electric shocks.
Nebuliser, mouthpiece and masks are type BF applied parts.
Please report any serious incident that has occurred in relation
to the device, injury or adverse event to the local competent
authority and to the manufacturer or to the european authorised
representative (EC REP).
Vigilance contact point:
https:/ec.europa.eu/growth/sectors/medical-devices/contacts
AEROSOL CHARACTERISTICS IN ACCORDANCE WITH
REGULATION EN ISO27427
Standards applied:
Electric safety standards CEI EN 60601-1 electromagnetic
compatibility according to CEI EN 60601-1-2.
The device is a Class IIa medical device.
Device complies with European Regulation on medical
devices EU MDR 2017/745.
Important information regarding Electromagnetic
Compatibility (EMC):This product, manufactured by Globalcare
Medical Technology Co., Ltd., conforms to the Electromagnetic
Compatibility (EMC) standard EN 60601-1-2:2015/A1:2021.
Further documentation in compliance with this EMC standard is
available from Microlife on www.microlife.com/electro-magnetic-
compatibility.
Large particle range
(> 5 µm): 36.7 %
Middle particle range
(3-5 µm): 12 %
Small particle range
(< 3 µm): 51.3 %
Operating air flow: 5.31 l/min.
Acoustic noise level: 52 dBA
Power source: 230V 50 Hz AC
Current: ≤ 1000 mA
Power lead length: 1.6 m
Nebuliser capacity: min. 2 ml; max. 8 ml
Operating limits: 30 min. On / 30 min. Off
Operating
conditions:
10 – 40 °C / 50 – 104 °F
10 – 95 % relative maximum humidity
700 – 1060 hPa Atmospheric pressure
Storage and shipping
conditions:
-25 – +70 °C / -4 – +140 °F
10 – 95 % relative maximum humidity
700 – 1060 hPa Atmospheric pressure
Weight: approx. 1306 g
Dimensions: 103 x 160 x 140 mm
IP Class: IP21
Reference to
standards:
EN ISO 27427; EN 60601-1; EN 60601-
1-2; EN 60601-1-6; IEC 60601-1-11
Expected service life: 1000 hours
The technical specifications may change
without prior notice.
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